Risultati per: Centri di riferimento HCV - MOLISE

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Introduction
Hepatitis C virus (HCV) infection is a silent epidemic that needs a comprehensive and contextualised approach to manage. Access to readily available, affordable and acceptable HCV point-of-care (POC) in vitro diagnostics (IVDs) is equally required to meet the global HCV goals. However, most guidelines for evaluating these IVDs such as the WHO prequalification process and country-specific standards disproportionately focus on diagnostic performance. The real-time connectivity, ease of specimen collection, affordability, sensitivity, specificity, user-friendliness, rapidity and robustness, equipment-free or simplicity and deliverability to end-users (REASSURED) criteria provide a holistic and user-oriented evaluation of the IVDs in the populations they are meant to be used. Therefore, as part of a multinational study in sub-Saharan Africa, we will conduct an evaluation of the Bioline HCV POC test for diagnosing HCV infection in primary healthcare settings of Ghana using the REASSURED criteria.

Methods and analysis
This field evaluation will be conducted in three phases. The first phase will use a cross-sectional field evaluation study design to evaluate the diagnostic performance of the Bioline HCV POC test. The second phase will use mixed methods to ascertain operational characteristics and users’ perceptions. In the third phase, a cross-sectional survey will be used to estimate the costs of accessing HCV diagnostics services using three proposed HCV testing models to inform the affordability of the testing pathways and linkage to care in the primary healthcare clinics. This phase will run concurrently with the second phase of the study. Thematic content analysis and quantitative data analysis will be performed using ATLAS.ti V.23.0.6 and StataCorp LLC’s Stata statistical software V.16.0, respectively.

Ethics and dissemination
The study protocol has been reviewed and fully approved by the Faculty of Health Sciences Research Ethics Committee, University of Pretoria (281/2023) and the Ghana Health Service Ethics Review Committee (GHS-ERC013/08/23). This diagnostic trial has also been registered in the Pan African Clinical Trial Registry (PACTR202410837698664). The findings of the study will be presented in relevant peer-reviewed journals, at local and international conferences, and to all stakeholders involved.

Chronic hepatitis C(CHC) related decompensated cirrhosis is associated with lower SVR-12 rates and variable regression of disease severity following direct-acting antiviral agents (DAAs). We assessed rates of SVR-12, recompensation (Baveno VII criteria), and survival in such patients.

Introduction
Previous studies have shown that substantial percentages of emergency department (ED) patients in the USA recommended for HIV or hepatitis C (HCV) decline testing. Evidence-based and cost-effective interventions to improve HIV/HCV testing uptake are needed, particularly for people who inject drugs (PWIDs) (currently or formerly), who comprise a group at higher risk for these infections. We developed a brief persuasive health communication intervention (PHCI) designed to convince ED patients who had declined HIV/HCV testing to agree to be tested. In this investigation, we will determine if the PHCI is more efficacious in convincing ED patients to be tested for HIV/HCV when delivered by a video or in person, and whether efficacy is similar among individuals who currently, previously or never injected drugs.

Methods and analysis
We will conduct a multisite, randomised controlled trial comparing PHCIs delivered by video versus in person by a health educator to determine which delivery method convinces more ED patients who had declined HIV/HCV testing instead to be tested. We will stratify randomisation by PWID status (current, former or never/non-PWID) to permit analyses comparing the PHCI delivery method by injection-drug use history. We will also perform a cost-effectiveness analysis of the interventions compared with current practice, examining the incremental cost-effectiveness ratio between the two interventions for the ED population overall and within individual strata of PWID. As an exploratory analysis, we will assess if a PHCI video with captions confers increased or decreased acceptance of HIV/HCV testing, as compared with a PHCI video without captions.

Ethics and dissemination
The study protocol has been approved by the institutional review board of the Icahn School of Medicine. The results will be disseminated at international conferences and in peer-reviewed publications.

Trial registration number
NCT05968573.

Ancora difficoltà nel reperire personale specializzato

The high genetic diversity of hepatitis C virus (HCV) has led to the emergence of eight genotypes and a large number of subtypes in limited geographical areas. Currently approved pangenotypic DAA regimens have been designed and developed to be effective against the most common subtypes (1a, 1b, 2a, 2b, 2c, 3a, 4a, 5a and 6a). However, large populations living in Africa and Asia, or who have migrated from these regions to industrialised countries, are infected with ‘unusual’, non-epidemic HCV subtypes, including some that are inherently resistant to currently available direct-acting antiviral (DAA) drugs due to the presence of natural polymorphisms at resistance-associated substitution positions. In this review article, we describe the origin and subsequent global spread of HCV genotypes and subtypes, the current global distribution of common and unusual HCV subtypes, the polymorphisms naturally present in the genome sequences of unusual HCV subtypes that may confer inherently reduced susceptibility to DAA drugs and the available data on the response of unusual HCV subtypes to first-line HCV therapy and retreatment. We conclude that the problem of unusual HCV subtypes that are inherently resistant to DAAs and its threat to the global efforts to eliminate viral hepatitis are largely underestimated and warrant vigorous action.

Objectives
Hepatitis C virus (HCV) infection poses a global health challenge. By the end of 2021, the WHO estimated that less than a quarter of global HCV infections had been diagnosed. There is a need for a public health tool that can facilitate the identification of people with HCV infection and link them to testing and treatment, and that can be customised for each country.

Methods
We derived and validated a risk score to identify people with HCV in Egypt and demonstrated its utility. Using data from the 2008 and 2014 Egypt Demographic and Health Surveys, two risk scores were constructed through multivariable logistic regression analysis. A range of diagnostic metrics was then calculated to evaluate the performance of these scores.

Results
The 2008 and 2014 risk scores exhibited similar dependencies on sex, age and type of place of residence. Both risk scores demonstrated high and similar areas under the curve of 0.77 (95% CI: 0.76 to 0.78) and 0.78 (95% CI: 0.77 to 0.80), respectively. For the 2008 risk score, sensitivity was 73.7% (95% CI: 71.5% to 75.9%), specificity was 68.5% (95% CI: 67.5% to 69.4%), positive predictive value (PPV) was 27.8% (95% CI: 26.4% to 29.2%) and negative predictive value (NPV) was 94.1% (95% CI: 93.5% to 94.6%). For the 2014 risk score, sensitivity was 64.0% (95% CI: 61.5% to 66.6%), specificity was 78.2% (95% CI: 77.5% to 78.9%), PPV was 22.2% (95% CI: 20.9% to 23.5%) and NPV was 95.7% (95% CI: 95.4% to 96.1%). Each score was validated by applying it to a different survey database than the one used to derive it.

Conclusions
Implementation of HCV risk scores is an effective strategy to identify carriers of HCV infection and to link them to testing and treatment at low cost to national programmes.

Objectives
Migrants from high HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) endemicity regions have a great burden of these infections and related diseases in the host countries. This study aimed to assess the predictive capacity of the Test Rapide d’Orientation Diagnostique (TROD) Screen questionnaire for HIV, HBV and HCV infections among migrants arriving in France.

Design
An observational and multicentre study was conducted among migrants. A self-questionnaire on demographic characteristics, personal medical history and sexual behaviours was completed.

Setting
The study was conducted in the centres of the French Office for Immigration and Integration (OFII).

Participants
Convenience sampling was used to select and recruit adult migrants between January 2017 and March 2020.

Outcome measures
Participants were tested for HIV, HBV and HCV with rapid tests. For each infection, the test performance was assessed using receiver operating characteristics curves, using area under the curve (AUC) as a measure of accuracy.

Results
Among 21 133 regular migrants seen in OFII centres, 15 343 were included in the study. The participants’ mean age was 35.6 years (SD±11.1). The prevalence (95% CI) of HBV, HCV and HIV was 2.0% (1.8% to 2.2%), 0.3% (0.2% to 0.4%) and 0.3% (0.2% to 0.4%), respectively. Based on the sensitivity–specificity curve analysis, the cut-off points (95% CI) chosen for the risk score were: 2.5 (2.5 to 7.5) for HBV infection in men; 6.5 (0.5 to 6.5) for HBV infection in women; 9.5 (9.5 to 12.5) for HCV infection; and 10.5 (10.0 to 18.5) for HIV infection. Test performance was highest for HIV (AUC=82.15% (95% CI 74.54% to 87.99%)), followed by that for HBV in men (AUC=79.22%, (95% CI 76.18% to 82.26%)), for HBV in women (AUC=78.83 (95% CI 74.54% to 82.10%)) and that for HCV (AUC=75.95% (95% CI 68.58% to 83.32%)).

Conclusion
The TROD screen questionnaire showed good overall performance for predicting HIV, HBV and HCV infections among migrants in OFII centres. It could be used to optimise screening for these infections and to propose rapid screening tests to those who are at high risk.

Trial registration number
NCT02959684.